Monday, 10 April 2017

Centre's move to shift DoP, NPPA under health ministry viewed game changer for Indian pharma

Union
government’s plan to shift the department of pharmaceuticals and NPPA
under the Ministry of health could turn out to be a major administrative
step on the Indian healthcare landscape, noted pharma experts and the
industry. They view it as game changer for the sector provided its
happens in a time bound manner.

According to Dr B R Jagashetty,
former National Adviser (Drugs Control) to MoHFW & CDSCO and former
Karnataka drugs controller, all issues related to medicines be it
biotech, Ayush and veterinary should come under the umbrella of the
Ministry of Health and Family Welfare(MoHFW).

“Though there is
nothing wrong in having a separate full-fledged Ministry combining the
issues of both drugs and food like that of Maharashtra, the present
decision to bring DoP and the NPPA under the MoHFW instead of having a
separate ministry of pharmaceuticals, is relevant and a welcome move.
However, its implementation needs to be fast-tracked,” said Dr.
Jagashetty.

Currently, biotech is under the information
technology department. Now this sector deals with fermentation
technology for the development of monoclonal antibodies which needs drug
approvals. Therefore it should also come under MoHFW, he added.

While
the government is toying with the idea of having more than one
secretary to man the MoHFW, Dr. Jagashetty begs to differ on this and
calls for one authoritative official to oversee the operations. The
medicines quality standards, its pricing or any issues concerned with
public health should be only approved by the DCGI office and related
state drugs control departments which will be functioning under MoHFW.

With
regards to NPPA, Dr. Jagashetty pointed out that once this body comes
under the MoHFW, the government will need to stall the frequent revision
of drug prices which is causing considerable confusion to the industry,
distributors and patients. Hence the government with the assistance of
DCGI should consider a decision to revise drug prices only twice or
thrice a year. The frequent change in prices is also resulting in loss
of inventory which includes packaging, labelling and stocking, besides
being a national burden.

Kaushik Desai, Gen. Secretary, Indian
Pharmaceutical Association and pharma consultant noted the if the move
materialises, it is laudable. There will be only one Ministry
accountable for making quality medicines affordable and accessible. It
will result in better interdepartmental coordination between NPPA, CDSCO
and DoP. If done effectively, it will help in ease of doing business in
the true sense and support industrial growth.

“Moreover, it
would bring some relief to industry as any new notification will be
weighted by DoP before release. We hope it will bring clarity on the
frequent changes in drug pricing by making it patient friendly,” said
Desai.

Viewing the proposed move by PMO to bring NPPA & DOP
along with CDSCO as a step in the right direction, Harish Jain,
secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association
pointed out that it will lead to better co-ordination and avoid
duplication of efforts.

“However, whether all these departments
should come under Health Ministry is open to debate. Instead, PMO should
look at total revamp rather than adopt a partial approach. There should
be a mega Ministry of Life Sciences comprising pharmaceuticals, Ayush,
vaccines & sera, biopharmaceuticals, medical devices and
nutraceuticals, headed by a minister of cabinet rank. It can oversee
licensing, testing enforcement, NIPER, Export Promotion Councils, Jan
Aushadhi, besides create appellate tribunals for speedy settlement of
disputes", said Jain.